Early detection of carcinoma in situ of the testis with a new non-invasive method.

Completed

• Conditions: Carcinoma in situ; pre-stage testicular cancer; 10038588; 10013362

• Registration Number: NL-OMON39915
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 403

Inclusion Criteria

Men of 18 years and older with:
- Patientgroup 1: riskfactors for TGCT
- Patientgroup 2: riskfactors for TGCT and testicular microcalcifications
- Controlegroep 1: normospermia and no riskfactors for TGCT
- Controlegroep 2: proven fertility

Exclusion Criteria

- Men < 18 years
- Retrograde ejaculation
- Sterlised
- Previous chemotherapy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Reproductive hormones; FSH, LH, testosterone and Inhibin-B<br /><br>- DNA-isolation from blood: identification of TGCT risico SNPs<br /><br>- Semen analysis; volume, concentration, number, motility and pH<br /><br>- Semen diagnostic on the presence of OCT3/4 immunohistochemistry<br /><br>- Semen diagnostic on the presence of TGCT miRNA<br /><br>- Andrological history / Andrological history through web-based questionnaire<br /><br>- Physical examination of the scrotum<br /><br>- Scrotal ultrasound<br /><br>- Testis biopsy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>